- •A measurable antibody response requires several weeks to develop, commonly persists after successful treatment, and is not prevented by noncurative therapy.
- •Immunoglobulin (Ig)G rather than IgM Western blots should be used after 1-2 months of illness.
- •No clinical manifestation except erythema migrans allows diagnosis without laboratory confirmation.
- •Two to 4 weeks of oral antibiotics usually suffices, with parenteral antimicrobials reserved for severe involvement.
- •Lyme encephalopathy is not evidence of brain infection.
|False negatives||“Blood tests are unreliable with many negatives in patients who really have Lyme disease”||Just as with all antibody-based testing, these are often negative very early before the antibody response develops (<4-6 weeks). They are rarely if ever negative in later disease|
|Isolated IgM seropositivity||“Patients with many months of symptoms may have only a positive IgM Western blot”||Because the IgG response develops in 4-6 weeks, patients with symptoms of longer duration than this should be IgG positive; isolated IgM bands in such patients are almost always a false+|
|Seropositivity after treatment||“Positive blood tests after treatment mean more treatment is needed”||After any infection resolves, the immune system continues to produce specific antibodies for an extended period. This is not an indication of persistent infection|
|Antibiotics effect on serologic tests||“Antibiotics make blood tests negative during treatment”||There is no evidence that this happens and no biologic reason it would|
|The clinical diagnosis of Lyme disease||“Lyme disease is a clinical diagnosis that should be made based on a list of symptoms”||No clinical features, except erythema migrans or possibly bilateral facial nerve palsy—in the appropriate context—provide sufficient specificity or positive predictive value. Laboratory confirmation is essential except with erythema migrans|
|Persisting fatigue & cognitive symptoms in isolation as evidence of brain infection||“Patients with fatigue and memory difficulties have Borrelia burgdorferi infection of the brain”||These symptoms are not specific for B. burgdorferi infection and only rarely are evidence of a brain disorder.|
|Severity of Lyme disease||“B. burgdorferi infection is potentially lethal”||Although Lyme disease can cause heart or brain abnormalities, there have been remarkably few—if any—deaths attributable to this infection|
|Prolonged treatment||“If, following treatment, symptoms persist, or serologic testing remains positive, additional treatment is required”||Multiple well-performed studies demonstrate that recommended treatment courses cure this infection. Retreatment is necessary occasionally, but not frequently|
|Symptomatic improvement on antibiotics as validation of the diagnosis||“Rapid symptomatic improvement on treatment proves the diagnosis despite negative blood tests”||Non-microbicidal effects of antibiotics may result in symptomatic improvement. In controlled trials, 1 patient in 3 improved in response to placebo.|
Diagnosis: Are Serologic Tests for Lyme Disease Reliable?
Does Antibiotic Therapy Affect Seropositivity for Lyme Disease During Treatment?
Is Persistent Seropositivity Following Treatment Significant?
Is Isolated IgM Seropositivity Significant in Longstanding Infection?
Should Lyme Disease be Primarily a “Clinical Diagnosis”?
Is Persistent Fatigue and Perceived Memory and Cognitive Difficulty Evidence of Brain Infection Due to B. Burgdorferi?
Lyme Disease—Can it be Lethal?
Is There a Rationale for Longer Treatment Courses?
Does Symptomatic Improvement While on Antibiotic Therapy Confirm the Diagnosis of Lyme Disease?
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Funding: Dr Halperin receives funding from the Centers for Disease Control and Prevention (CDC); Dr Wormer has received research grants from CDC, the National Institutes of Health, Immunetics, Inc., BioRad, DiaSorin, Inc., and BioMerieux.
Conflict of Interest: Dr Halperin served as expert witness in medical malpractice cases defending physicians accused of failure to diagnose Lyme disease; he has no other conflicts. Dr Wormser: Equity in Abbott; expert witness in malpractice cases involving Lyme disease; unpaid board member American Lyme Disease Foundation; expert witness on Lyme disease in a disciplinary action for the Missouri Board of Registration for the Healing Arts; consultant to Baxter for Lyme vaccine development.
Authorship: All authors participated in the conceptualization and writing of this manuscript.